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Intra-Cellular Therapies Announces Positive Results for New Antipsychotic
Intra-Cellular Therapies has announced positive results from the first phase III clinical trial of ITI-007 for the treatment of patients with schizophrenia.
This randomized, double-blind, fixed-dose, placebo-controlled trial was conducted at 12 sites in the United States, with 450 patients randomized (1:1:1) to receive either ITI-007 60 mg or 40 mg or placebo once daily in the morning for four weeks. Patients were diagnosed with schizophrenia (using DSM-5 criteria) and were required to have an acute exacerbation of psychotic symptoms.
The prespecified primary efficacy measure was change from baseline versus placebo at the study endpoint (four weeks) on the centrally rated Positive and Negative Syndrome Scale (PANSS) total score. The key secondary endpoint was the centrally rated Clinical Global Impression Scale for Severity of Illness (CGI-S). Trial participants had a mean PANSS score of 89.8 at baseline, indicative of being markedly ill. Once-daily morning dosing allowed for comprehensive safety assessments during the day throughout the study, including measurement of cardiovascular function, vital signs, body weight, and laboratory assessments. This is the first of two phase III clinical trials intended to evaluate the efficacy, safety, and tolerability of ITI-007 for the treatment of schizophrenia.
In this trial, once-daily ITI-007 60 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at week 4 as measured by the change from baseline on the PANSS total score (P = 0.022).
Moreover, ITI-007 60 mg showed significant antipsychotic efficacy as early as week 1; this efficacy was maintained at every time point throughout the study. ITI-007 60 mg also met the key secondary endpoint of statistically significant improvement on the CGI-S (P = 0.003).
Intra-Cellular also announced top-line data from a separate clinical study using positron emission tomography in patients with schizophrenia. In this trial, ITI-007 60 mg was associated with a mean of approximately 40% striatal dopamine receptor occupancy. ITI-007 demonstrated antipsychotic effect at relatively low striatal dopamine receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs. Unlike existing schizophrenia treatments, this dopamine receptor phosphoprotein modulator acts as a presynaptic partial agonist and postsynaptic antagonist at dopamine receptors. This mechanism likely contributes to the favorable safety profile of ITI-007, with reduced risk for hyperprolactinemia, akathisia, extrapyramidal symptoms, and other motor side effects.
The data from both clinical trials will be presented at upcoming scientific meetings.
Source: Intra-Cellular Therapies; September 16, 2015.